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Completed

NCT Number: NCT02380469

Improvement of Information to Cancer Patients' Caregivers

The purpose of this study is to investigate whether a systematic early assessment of uncovered needs for information, supplemented by an interview about the needs with the patient's nurse who seeks to provide the information requested, will improve the caregivers' and the patients' satisfaction with information and communication and potentially also decrease anxiety and depression.

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Key information

Conditions

Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Oncology, Herlev Hospital

Herlev, 2730, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Patient Inclusion Criteria:

  • Cancer patient
  • Newly refered to (i.e., this is the patient's first visit in) Department of Oncology, Herlev Hospital, in order to start medical treatment (e.g. chemotherapy)
  • Written informed consent

Caregiver Inclusion Criteria:

  • Attends the first visit in the Department of Oncology with the patient
  • Has lacked information about at least one of the 13 aspects of information asked about in the questionnaire
  • Written informed consent

Exclusion criteria

  • Patient and/or caregiver do not understand Danish well enough to participate in the study
  • The patient has an expected survival of less than six months

Treatment and study plan

Identification and provision of lacking information

Behavioral

The intervention consists of an interview about the caregiver's responses (baseline measurement) to a list about 'lack of information' within 13 areas. For each area, the patient's nurse will enquire about what information is requested by the caregiver and the patient. Subsequently, the nurse provides the requested information. She may involve the doctor and arrange follow-up visits or phone calls until the need is covered

Primary outcomes

  1. Satisfaction with information from health care professionals

    Time frame: Change from baseline (enrollment) at 2 weeks

    Measure: The "Cancer Caregiving Tasks, Consequences and Needs Questionnaire" (CaTCoN) item 24

Secondary outcomes

  1. Satisfaction with information from health care professionals

    Time frame: Change from baseline (enrollment) at 2 weeks

    Measure: CaTCoN subscale "Lack of information from health care professionals" (revised version)

  2. Satisfaction with communication with health care professionals

    Time frame: Change from baseline (enrollment) at 2 weeks

    Measure: CaTCoN subscale "Problems with the quality of information and communication from health care professionals"

  3. Satisfaction with support from health care professionals

    Time frame: Change from baseline (enrollment) at 2 weeks

    Measures: CaTCoN subscale "Lack of attention from health care professionals on the caregivers' wellbeing"

  4. Satisfaction with support from health care professionals

    Time frame: Change from baseline (enrollment) at 2 weeks

    Measures: CaTCoN subscale "Need for help from health care professionals"

  5. Anxiety and depression

    Time frame: Change from baseline (enrollment) at 2 weeks

    Measure: The Hospital Anxiety and Depression Scale (HADS)

  6. Fulfillment of needs

    Time frame: Change from baseline (enrollment) at 2 weeks

    Measure: Family Inventory of Needs (FIN)

Other outcomes

  1. The time spent on information as reported by health care professionals

    Time frame: Weeks 0-6 from baseline

    Investigated in focus group interviews with the health care professionals

  2. Satisfaction with information from health care professionals

    Time frame: Change from baseline (enrollment) at 12 weeks

    Measure: CaTCoN item 24

  3. Satisfaction with information from health care professionals

    Time frame: Change from baseline (enrollment) at 12 weeks

    Measure: CaTCoN subscale "Lack of information from health care professionals" (revised version)

  4. Satisfaction with communication with health care professionals

    Time frame: Change from baseline (enrollment) at 12 weeks

    Measure: CaTCoN subscale "Problems with the quality of information and communication from health care professionals"

  5. Satisfaction with support from health care professionals

    Time frame: Change from baseline (enrollment) at 12 weeks

    Measures: CaTCoN subscale "Lack of attention from health care professionals on the caregivers' wellbeing"

  6. Satisfaction with support from health care professionals

    Time frame: Change from baseline (enrollment) at 12 weeks

    Measures: CaTCoN subscale "Need for help from health care professionals"

  7. Anxiety and depression

    Time frame: Change from baseline (enrollment) at 12 weeks

    Measure: The Hospital Anxiety and Depression Scale (HADS)

  8. Fulfillment of needs

    Time frame: Change from baseline (enrollment) at 12 weeks

    Measure: Family Inventory of Needs (FIN)

Sponsors and collaborators

Lead sponsor

Bispebjerg Hospital

Other

Collaborators

  • Danish Cancer Society
  • Herlev Hospital

Registry information

Official study title

Improvement of Information to Cancer Patients' Caregivers: a Randomised Intervention Study

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 5, 2015
Registry last updated
Jan 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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